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Purpose of the study is the evaluation of the applicability of the percutaneous technique through double Proglide and Pre-Close Technique to the treatment of complex aortic aneurysms with thoracic endoprosthesis (TEVAR), fenestrated or branched (F / B-EVAR) in which patient-related factors, the devices used or the procedure, could affect the performance.
Endovascular treatment using a percutaneous technique (Percutaneous Endovascular Aneurism Repair - P-EVAR) has been used with increasing frequency to treat aortic aneurysms by reducing operative times, postoperative pain and length of stay, compared to treatment by surgical femoral access. During EVAR procedures, two accesses to the femoral arteries are required to introduce the necessary tools for the stentgraft implantation. Such accesses can be classically obtained by surgical incision, isolation of the common femoral arteries and direct introduction of the devices.
Alternatively, the most modern approach involves direct puncture of the artery (without the need for incision), through the skin and closure of the arterial breach through prolonged manual compression of the vascular closure or systems (Vascular Closure Devices - VCD) specifically designed. Among the various closure devices one of the most used and studied is the Perclose Proglide (Abbott Vascular, Santa Clara CA, USA) that allows to affix a polypropylene stitch to close the arterial breach. When closing high-caliber accesses (> 8 French) it is necessary to use two devices that must be positioned before inserting the introducer ("Pre-Close Technique").
Few studies have so far evaluated the application of this method to the treatment of complex cases such as thoracic or thoracoabdominal aortic aneurysms that requiring the use of high caliber introducers.
The objective of the study is the evaluation of the technical success and clinical outcomes of the PEVAR technique with a double vascular suture device Perclose ProGlide (Abbott Illinois, U.S.A.).Endovascular treatment using a percutaneous technique (Percutaneous Endovascular Aneurism Repair - P-EVAR) has been used with increasing frequency to treat aortic aneurysms by reducing operative times, postoperative pain and length of stay, compared to treatment by surgical femoral access. During EVAR procedures, two accesses to the femoral arteries are required to introduce the necessary tools for the stentgraft implantation. Such accesses can be classically obtained by surgical incision, isolation of the common femoral arteries and direct introduction of the devices.
Alternatively, the most modern approach involves direct puncture of the artery (without the need for incision), through the skin and closure of the arterial breach through prolonged manual compression of the vascular closure or systems (Vascular Closure Devices - VCD) specifically designed. Among the various closure devices one of the most used and studied is the Perclose Proglide (Abbott Vascular, Santa Clara CA, USA) that allows to affix a polypropylene stitch to close the arterial breach. When closing high-caliber accesses (> 8 French) it is necessary to use two devices that must be positioned before inserting the introducer ("Pre-Close Technique").
Few studies have so far evaluated the application of this method to the treatment of complex cases such as thoracic or thoracoabdominal aortic aneurysms that requiring the use of high caliber introducers.
The objective of the study is the evaluation of the technical success and clinical outcomes of the PEVAR technique with a double vascular suture device Perclose ProGlide (Abbott Illinois, U.S.A.).
This is a retrospective observational study (320 cases treated in San Raffaele hospital in Milan, during the period: October 2015 - 31 December 2019).
The chronology of the assessments will include:
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| Measure | Description | Time Frame |
|---|---|---|
| technical success | Use of femoral artery access in endovascular repair of aortic aneurysm (time frame between 2015 and 2020)
| during the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| minor complications | Femoral access vascular anatomy and patient's characteristics (time frame between 2015 and 2020):
|
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Inclusion Criteria:
Exclusion Criteria:
- There are no criteria for exclusion of subjects from the study.
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a sample of 320 subjects will be analyzed (considering the cases treated in the period: October 2015 - 31 december 2019).
The analysis of the retrospective data, will be based on the consultation of the archive of the individual treated patients, present on software platform belonging to the San Raffaele Hospital Information System) as well as the medical records.
An informatic database will be set up for the exclusive use of investigators. The data will be analyzed subsequently through the application of descriptive and inferential statistics techniques.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32442603 | Derived | Melloni A, Grandi A, Spelta S, Salvati S, Loschi D, Lembo R, Melissano G, Chiesa R, Bertoglio L. Outcomes of routine use of percutaneous access with large-bore introducer sheaths (>21F outer diameter) during endovascular aneurysm repair. J Vasc Surg. 2021 Jan;73(1):81-91. doi: 10.1016/j.jvs.2020.04.504. Epub 2020 May 19. |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D017544 | Aortic Aneurysm, Abdominal |
| D017545 | Aortic Aneurysm, Thoracic |
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001014 | Aortic Aneurysm |
| D001018 | Aortic Diseases |
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| 30 days after surgery |